A phase II, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced nonsmall cell lung cancer (NSCLC) (CINC280A2201) - CINC280A2201 - GeoMETry Mono1

ovartis0 个研究点目标入组 28 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Female and male patients >= 18 years of age.
•Stage IIIB or IV NSCLC.
•Histologically or cytologically confirmed diagnosis of NSCLC (see protocol
•page 42 for details):
•EGFR wild-type.
•ALK-negative rearrangement.
•Pre-treated Patients with cMET GCN>=6 and <10 (cohort 1a), Patients with cMET
•GCN>=10 (cohort 1b), GCN>=4 and <6 (cohort 2), GCN<4 (cohort 3), cMET mutations
•(cohort 4). Treatment naive patients with cMET GCN >= 10 (cohort 5a), cMET
•mutations (cohort 5b), Pre-treated patients (1 treatment line) with either cMET
•GCN >= 10 without cMET mutations or cMET mutations regardless of cMET GCN
•(cohort 6 = expansion group). Treatment naive patients with cMET mutations,
•regardless of cMET GCN (Cohort 7 = expansion group)
•For cohort 1-4 patients must have received one or two prior lines of systemic
•therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). For cohort 5
•patients must have received no prior lines of systemic therapy for
•advanced/metastatic disease (stage IIIB or IV NSCLC). See protocol page 42 for
•Measurable disease. See protocol page 42 for details.
•ECOG performance status 0-1.

•Prior treatment with crizotinib, or any other cMET or HGF inhibitor.
•Characterized EGFR mutations that predict sensitivity to EGFR therapy.
•Characterized ALK-positive rearrangement.
•Symptomatic CNS metastases who are neurologically unstable or have required
•increasing doses of steroids within the 2 weeks prior to study entry.
•Clinically significant, uncontrolled heart diseases. See protocol page 44 for
•Thoracic radiotherapy to lung fields <= 4 weeks prior to starting INC280. For
•all other anatomic sites, radiotherapy <= 2 weeks prior to starting INC280.
•Palliative radiotherapy for bone lesions <= 2 weeks prior to starting INC280 is
•allowed. See protocol page 44 for details.
•Major surgery within 4 weeks prior to starting INC280. See protocol page 44
•for details.
•Strong and moderate inhibitors of CYP3A4, strong inducers of CYP3A4, proton
•pump inhibitors.
•Unstable or increasing doses of corticosteroids, enzyme-inducing
•anticonvulsant. See protocol page 45 for details)
•Pregnancy, lactation, insufficient contraception for females of childbearing
•Sexually active males unless they use a condom during intercourse.

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